Early Phase 1
Completed N=35
Remediation of Impaired Self-Regulation in Patients With Mild TBI
Source: ClinicalTrials.gov NCT02260570 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Blood Oxygen Level Dependent (BOLD) Brain Signal Measured Using Functional MRI. — 270; 111 voxels — p=<0.0001
Summary
The ability to regulate impulses enables us to plan for the future, to maintain focus in the face of distractions (i.e. to encode memories), and to manage emotions. This self regulation can be compromised in individuals who have a history of mild traumatic brain injury and co-occurring disorders. In this study the investigators are using functional MRI scanning to understand how memory and self regulation are expressed in the brains of people with a history of mild traumatic brain injury. The investigators are also testing whether the medication tolcapone may improve memory and self regulation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Oxygen Level Dependent (BOLD) Brain Signal Measured Using Functional MRI. |
270; 111 | <0.0001 sig |
| PRIMARY Performance on Cognitive Testing |
25.4; 25.4 | 0.0184 sig |
Eligibility Criteria
Inclusion Criteria
- Veteran ages 18-50 and in general good health;
- Able to read English at a 6th grade level;
- Able to provide written informed consent;
- Normal or corrected to normal visual acuity;
- Stable doses of all medications (2 weeks or greater);
- History of mild traumatic brain injury greater than 6 months prior to participation
Exclusion Criteria
- Contraindications to magnetic resonance imaging (MRI) scanning;
- Inability to complete basic fMRI requirements;
- History of brain surgery or penetrating brain injury;
- Uncontrolled blood pressure (low or high);
- Contraindications to tolcapone use;
- Use of medications or drugs with dopamine-related actions within 30 days;
- Active substance abuse or dependence;
- Clinically severe medical illness requiring treatment;
- History of psychiatric hospitalization (past 1 year) or suicide attempt (past 5 years);
- Seizures greater than 4 weeks after traumatic brain injury (TBI) event or seizures requiring active treatment;
- History of brain tumor, stroke, Alzheimer's disease, aneurysm rupture, or multiple sclerosis;
- History of schizophrenia, attention deficit hyperactivity disorder (ADHD) or psychiatric diagnosis EXCEPT depression or post-traumatic stress disorder (PTSD)
Data sourced from ClinicalTrials.gov (NCT02260570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.